MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; INTRA-AORTIC BALLOON

Catalog Number IAB-06840-U

Device Problem Kinked (1339)

Patient Problems Myocardial Infarction (1969); Ventricular Fibrillation (2130); Cardiogenic Shock (2262)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).Sample will not be returned for evaluation.

Event Description

It was reported that the rn was calling to troubleshoot multiple alarms on the pump (s/n (b)(4)).The intra-aortic balloon (iab) was placed on (b)(6) 2016.The patient (pt) returned to the cath lab for pacer insertion.The pump was pumping "well, waveforms looked appropriate." pt was stable.Since returning from the cath lab, there were helium loss, high baseline and high pressure alarms.There was no visible kink and no blood in the catheter.An x-ray was ordered to confirm placement.They disconnected and reconnected the tubing as suggested by the sales representative to reduce the pressure in the gas line.The clinical support specialist (css) discussed the bpw (balloon pressure waveform) with the rn.There was kinking noted based on wide / sloped artifact.On further assessment the balloon plateau pressure was 135 and the augmented was 95.The css discussed decreasing the volume until the proper size was reached.The css reminded the rn that the iab must remain 2/3 full to avoid clot formation.The css stated that the rn should also discuss this with the doctor's.Pt positioning techniques were reviewed.At 1130 follow up call.The volume had been decreased to 35cc; continuing to get alarms although less frequent.The css discussed that the ratio could also be decreased, but at a certain point therapy was ineffective.A leak could not be ruled out and catheter entrapment would be a potential complication.If pumping was ineffective then they should consider exchanging the catheter.At 1631 a call from the md stated the alarms were continuing, no blood noted in tubing.The md considered removing the iab and was confirming this was recommended.The css reviewed the previous discussions with the md who stated they were in agreement and would remove the iab.Pt remained stable.At 1734 another health care professional called to discuss removal and review previous troubleshooting.She stated that they decided to remove the iab and monitor how the pt did without the pump.The css asked if it was still alarming and she stated that they had "turned it off." she stated that was an hour ago "and they have to take it out now right, since it's been longer than 30 minutes." the css confirmed and explained that clotting on the iab membrane was a concern and pt should be monitored for complications.She reported that they are going to remove it immediately.At 1900 the css called to follow up and spoke to the rn now caring for the pt.The rn stated that the md chose to remove the iab in the am and resumed pumping; but in a 1:4 ratio so the alarm had stopped.There was no blood noted in the catheter and no complications with the pt.The pt was stable on the pump.On (b)(6) 2016 at 0900 the css called to follow up.The iab was removed without difficulty or complication this morning.The pt was stable off pump with no noted complications.The length of time prior to event was 24 hours +.Strips requested, but they were unable to fax, text or email photo or strip.Additional information was received on 26apr2016 from the clinical specialist manager.The reported incident was discussed with the rn on itu yesterday and it appeared that the iab was 'kinked' by the doctor's several times on insertion.The balloon integrity could have been compromised from this point on.The catheter did appear to have been left 'kinked' insitu.The balloon volume was reduced to accommodate the higher bpw, but the doctor's did not follow our recommendations for safety.There was a 'blood back' in the gas line very early on and though the nurses suggested it needed to be removed, the doctor's declined.The pump was 'switched off' following further blood back, with the balloon still insitu in the femoral artery.This was on the doctor's instructions.After a period of over 90 minutes the consultant cardiologist then instructed nurses to re-commence pumping.The pt's o2 demands dramatically increased following this to 100% sao2, and eventually the balloon was removed.A critical incident report was submitted by nursing staff to our registered body.The patient was currently critically ill and therapy was not restarted.

Manufacturer Narrative

(b)(4) no product was returned for evaluation.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in the helium pathway is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported that the rn was calling to troubleshoot multiple alarms on the pump (s/n (b)(4)).The intra-aortic balloon (iab) was placed on (b)(6) 2016.The patient (pt) returned to the cath lab for pacer insertion.The pump was pumping "well, waveforms looked appropriate." pt was stable.Since returning from the cath lab, there were helium loss, high baseline and high pressure alarms.There was no visible kink and no blood in the catheter.An x-ray was ordered to confirm placement.They disconnected and reconnected the tubing as suggested by the sales representative to reduce the pressure in the gas line.The clinical support specialist (css) discussed the bpw (balloon pressure waveform) with the rn.There was kinking noted based on wide / sloped artifact.On further assessment the balloon plateau pressure was 135 and the augmented was 95.The css discussed decreasing the volume until the proper size was reached.The css reminded the rn that the iab must remain 2/3 full to avoid clot formation.The css stated that the rn should also discuss this with the doctor's.Pt positioning techniques were reviewed.At 1130 follow up call.The volume had been decreased to 35cc; continuing to get alarms although less frequent.The css discussed that the ratio could also be decreased, but at a certain point therapy was ineffective.A leak could not be ruled out and catheter entrapment would be a potential complication.If pumping was ineffective then they should consider exchanging the catheter.At 1631 a call from the md stated the alarms were continuing, no blood noted in tubing.The md considered removing the iab and was confirming this was recommended.The css reviewed the previous discussions with the md who stated they were in agreement and would remove the iab.Pt remained stable.At 1734 another health care professional called to discuss removal and review previous troubleshooting.She stated that they decided to remove the iab and monitor how the pt did without the pump.The css asked if it was still alarming and she stated that they had "turned it off." she stated that was an hour ago "and they have to take it out now right, since it's been longer than 30 minutes." the css confirmed and explained that clotting on the iab membrane was a concern and pt should be monitored for complications.She reported that they are going to remove it immediately.At 1900 the css called to follow up and spoke to the rn now caring for the pt.The rn stated that the md chose to remove the iab in the am and resumed pumping; but in a 1:4 ratio so the alarm had stopped.There was no blood noted in the catheter and no complications with the pt.The pt was stable on the pump.On 20apr2016 at 0900 the css called to follow up.The iab was removed without difficulty or complication this morning.The pt was stable off pump with no noted complications.The length of time prior to event was 24 hours +.Strips requested, but they were unable to fax, text or email photo or strip.Additional information was received on 26apr2016 from the clinical specialist manager.The reported incident was discussed with the rn on itu yesterday and it appeared that the iab was 'kinked' by the doctor's several times on insertion.The balloon integrity could have been compromised from this point on.The catheter did appear to have been left 'kinked' insitu.The balloon volume was reduced to accommodate the higher bpw, but the doctor's did not follow our recommendations for safety.There was a 'blood back' in the gas line very early on and though the nurses suggested it needed to be removed, the doctor's declined.The pump was 'switched off' following further blood back, with the balloon still insitu in the femoral artery.This was on the doctor's instructions.After a period of over 90 minutes the consultant cardiologist then instructed nurses to re-commence pumping.The pt's o2 demands dramatically increased following this to 100% sao2, and eventually the balloon was removed.A critical incident report was submitted by nursing staff to our registered body.The patient was currently critically ill and therapy was not restarted.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: INTRA-AORTIC BALLOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5610914
• MDR Text Key: 43765927
• Report Number: 1219856-2016-00104
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F16B0033
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR